How to Conduct Clinical Trials in Children: A Tutorial

被引：20
|
作者：
Shakhnovich, Valentina [1 ,2 ]
Hornik, Christoph P. [3 ]
Kearns, Gregory L. [4 ]
Weigel, Jaylene [1 ]
Abdel-Rahman, Susan M. [1 ,2 ]
机构：
[1] Childrens Mercy Kansas City, Kansas City, MO 64108 USA
[2] Univ Missouri, Sch Med, Kansas City, MO 64108 USA
[3] Duke Univ, Durham, NC USA
[4] Arkansas Childrens Hosp, 800 Marshall St, Little Rock, AR 72202 USA
来源：
CTS-CLINICAL AND TRANSLATIONAL SCIENCE | 2019年 / 12卷 / 03期
关键词：
SINGLE-DOSE PHARMACOKINETICS; FAT-ABSORPTION; INFANTS; PREMATURE; TRIGLYCERIDE; DISPOSITION; PLECONARIL; EXPRESSION; ONTOGENY; DESIGN;
D O I：
10.1111/cts.12615
中图分类号：
R-3 [医学研究方法]; R3 [基础医学];
学科分类号：
1001 ;
摘要：
Despite a growing interest in, and commitment to, implementing pediatric clinical trials, approximately one in every five trials in children fails because of inappropriate study design, suboptimal experiment planning, or inadequate participant enrollment. This tutorial, presented from the perspectives of seasoned pediatric investigators, an experienced research coordinator, and an established pediatric clinical trials network, is designed to provide practical guidance for successfully implementing pediatric clinical trials at an academic center or another comparable institution.
引用
收藏
页码：218 / 230
页数：13
相关论文
共 50 条
  • [1] CLINICAL TRIALS IN ADPKD-HOW TO CONDUCT GOOD CLINICAL TRIALS IN ADPKD?
    Hawley, Carmel
    NEPHROLOGY, 2021, 26 : 15 - 16
  • [2] How to Conduct Clinical Trials of Personalized Cancer Therapies
    Clark-Garvey, Sean
    Milowsky, Matthew, I
    EUROPEAN UROLOGY FOCUS, 2022, 8 (03): : 667 - 669
  • [3] How to conduct clinical trials in elderly cancer patients: Clinical issues
    Droz, J. -P.
    Terret, C.
    CRITICAL REVIEWS IN ONCOLOGY HEMATOLOGY, 2006, 60 : S1 - S1
  • [4] CONDUCT OF CLINICAL TRIALS
    GALLOWAY, DB
    PETRIE, JC
    STEWART, KB
    WALKER, W
    LANCET, 1974, 1 (7864): : 1001 - 1001
  • [5] THE CONDUCT OF CLINICAL TRIALS
    不详
    NUTRITION REVIEWS, 1957, 15 (10) : 320 - 320
  • [6] HOW TO CONDUCT FERTILISER TRIALS
    WITHELL, ECB
    GREGG, PEH
    NEW ZEALAND JOURNAL OF AGRICULTURE, 1971, 123 (01): : 28 - &
  • [7] A tutorial on sensitivity analyses in clinical trials: the what, why, when and how
    Thabane, Lehana
    Mbuagbaw, Lawrence
    Zhang, Shiyuan
    Samaan, Zainab
    Marcucci, Maura
    Ye, Chenglin
    Thabane, Marroon
    Giangregorio, Lora
    Dennis, Brittany
    Kosa, Daisy
    Debono, Victoria Borg
    Dillenburg, Rejane
    Fruci, Vincent
    Bawor, Monica
    Lee, Juneyoung
    Wells, George
    Goldsmith, Charles H.
    BMC MEDICAL RESEARCH METHODOLOGY, 2013, 13
  • [8] A tutorial on sensitivity analyses in clinical trials: the what, why, when and how
    Lehana Thabane
    Lawrence Mbuagbaw
    Shiyuan Zhang
    Zainab Samaan
    Maura Marcucci
    Chenglin Ye
    Marroon Thabane
    Lora Giangregorio
    Brittany Dennis
    Daisy Kosa
    Victoria Borg Debono
    Rejane Dillenburg
    Vincent Fruci
    Monica Bawor
    Juneyoung Lee
    George Wells
    Charles H Goldsmith
    BMC Medical Research Methodology, 13
  • [9] Clinical trials in children - How are they implemented?
    Hirtz, DG
    Gilbert, PR
    Terrill, CM
    Buckman, SY
    PEDIATRIC NEUROLOGY, 2006, 34 (06) : 436 - 438
  • [10] How to conduct clinical trials for elderly patients with cancer (US perspective)
    Extermann, M.
    CRITICAL REVIEWS IN ONCOLOGY HEMATOLOGY, 2007, 64 : S23 - S23
12345